A Clinical Study to Validate BTL-001-2 ABPM (Ambulatory Non-Invasive Blood Pressure Sphygmomanometer) according to the British Hypertension Society Protocol.
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- BTL India Pvt Ltd
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to clinically validate non-invasive
概览
简要总结
The purpose of the protocol is to offer evidence of accuracy for the BTL-001-2 Ambulatory blood pressure monitoring device for the intended use in the adult population as per BHS protocol. The same arm sequential method with dual observer auscultation will be used to collect data. The procedure, data collection and data analysis methods that are followed in this protocol are as per The British Hypertension Society protocol for the evaluation of blood pressure measuring devices. The aim is to provide accurate data of non-invasive blood pressure (NIBP) to support validation of the BTL-001-2 ambulatory blood pressure monitoring device. The anticipated benefits of this study sought to outweigh the possible risk associated with the device. There are no known contraindications, other than those noted in study’s exclusion criteria, for use in the proposed clinical study or study population.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 15.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects should be at least 15 years of age.
- •Arm circumference between 14 cm.
- •Willing to participate must be able to provide an informed consent or have legally authorized representative consent to participate.
- •Subjects that can tolerate a waiting period for up to 1 hour.
排除标准
- •1.Arm circumference is less than 14 cm or greater than 50 cm.
- •Irregular heart rhythm (bigeminy, trigeminy, isolated ventricular premature beat (VPB),atrial fibrillation)
- •Korotkoffs sound K1 or K5 not audible.
- •Musculoskeletal disorder that prevents a non-invasive device to be inflated/deflated on the arm.
- •Unwilling to volunteer to participate and to sign the study specific informed consent form.
- •Patients suffering with Parkinson’s disease or other diseases with tremors.
- •Patients with coagulation disturbances.
- •Patients with serious mobility or other impairments without supervision.
- •Patients requiring urgency/emergency cardiac care
- •History of bleeding disorder and intake of anticoagulant medication
结局指标
主要结局
The primary objective of this study is to clinically validate non-invasive
时间窗: 1st reading | 2nd reading | 3rd reading | 4th reading | 5th reading | 6th reading | 7th reading
blood pressure measurement accuracy of the BTL-001-2 ABPM non invasive blood pressure monitoring device to the British Hypertension
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Society protocol requirements.
时间窗: 1st reading | 2nd reading | 3rd reading | 4th reading | 5th reading | 6th reading | 7th reading
次要结局
- Documenting adverse events (AEs) serious adverse events (SAEs),(and device deficiencies)
研究者
Dr Meghana Murthy
Vagus Super Specialty Hospital